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Geographic Atrophy Treatment Evaluation (GATE)

This study has been terminated.
(Treatment ineffective)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00890097
First received: April 27, 2009
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of AL-8309B ophthalmic solution versus vehicle when administered as a topical ocular drop for the treatment for geographic atrophy secondary to age-related macular degeneration.


Condition Intervention Phase
Geographic Atrophy
Age Related Macular Degeneration
 Drug: AL-8309B Ophthalmic Solution
Drug: AL-8309B Vehicle
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean annualized lesion enlargement rate from baseline [ Time Frame: Baseline, up to Month 30 ] [ Designated as safety issue: No ]
    As assessed with fundus autofluorescence imaging


Secondary Outcome Measures:
  • Mean change in best-corrected visual acuity (BCVA) from baseline to last visit [ Time Frame: Baseline, up to Month 30 ] [ Designated as safety issue: Yes ]
    As assessed with the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol

  • Mean change in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Quality of Life Instrument Scores from Baseline to Last Visit [ Time Frame: Baseline, up to Month 30 ] [ Designated as safety issue: No ]
    Validated visual function questionnaire used for collecting quality of life data from patients with age-related macular degeneration.


Enrollment: 772
Study Start Date: April 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-8309B 1.0%
AL-8309B ophthalmic solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
 Drug: AL-8309B Ophthalmic Solution
Active ingredients, 1.0% or 1.75%
Experimental: AL-8309B 1.75%
AL-8309B ophthalmic solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
 Drug: AL-8309B Ophthalmic Solution
Active ingredients, 1.0% or 1.75%
Placebo Comparator: Vehicle
AL-8309B vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
 Drug: AL-8309B Vehicle
Inactive ingredients used as placebo comparator

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing to give written informed consent, make required study visits, and follow instructions.
  • Able to administer eye drops or have a caretaker to administer the eye drops.
  • Study eye: Atrophy secondary to age-related macular degeneration, best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular media, and adequate pupillary dilation.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant, nursing, or not using adequate contraception.
  • Ocular disease in the study eye, other than non-exudative AMD.
  • History of cataract surgery in either eye within the past 3 months of screening.
  • History or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening.
  • Any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely.
  • Participation in an investigational drug or device study within 30 days of screening.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890097

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Sally Scheib, Sr. Clinical Lead Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00890097     History of Changes
Other Study ID Numbers: C-08-36
Study First Received: April 27, 2009
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Geographic Atrophy
AMD
age related macular degeneration
Geographic Atrophy Secondary amd

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013